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    Summary
    EudraCT Number:2005-005165-11
    Sponsor's Protocol Code Number:GETUG 16/0504
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-04-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2005-005165-11
    A.3Full title of the trial
    Etude randomisée multicentrique comparant l'efficacité d'une hormonothérapie courte par Zoladex® concomitante à une radiothérapie versus une radiothérapie exclusive dans le traitement de rattrapage des rechutes biologiques de cancer de la prostate après chirurgie
    A.4.1Sponsor's protocol code numberGETUG 16/0504
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFédération Nationale des Centres de Lutte Contre le Cancer
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name ZOLADEX®
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZOLADEX®
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgoséréline
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Avec 40 000 nouveaux cas par an en France, le cancer de la prostate est le second cancer pour l’ensemble de la population française et le premier chez l’homme.
    L'hormonothérapie est le traitement standard des cancers de prostate métastatiques non opérés mais deux essais randomisés indépendants ont fait la preuve de l’efficacité d’une hormonothérapie concomitante à une radiothérapie conventionnelle de la prostate dans les formes localisées de mauvais pronostic.

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version V.8
    E.1.2Level LLT
    E.1.2Classification code 10060862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparer l’efficacité de l’association hormonothérapie courte par Zoladex® (6 mois) + radiothérapie de la loge prostatique (+/- pelvis) à une radiothérapie seule de la loge prostatique (+/- pelvis) sur la survie sans progression biologique et/ou clinique, dans le traitement de la rechute biologique de cancer de la prostate traité chirurgicalement.
    E.2.2Secondary objectives of the trial
    - Evaluer la survie globale.
    - Evaluer la survie spécifique sans métastase.
    - Evaluer les toxicités aiguës et tardives.
    - Evaluer le délai d’obtention du nadir du taux de PSA.
    - Evaluer la qualité de vie des patients au décours (1 an) et à distance (5 ans) de l’irradiation.
    - Evaluer la dépendance fonctionnelle des patients de plus de 75 ans au décours (1 an) et à distance (5 ans) de l’irradiation.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Patient âgé de 18 ans ou plus.
    - Patient porteur d’un adénocarcinome de prostate localisé (pT2, pT3, ou pT4 par atteinte du col vésical) traité par chirurgie exclusive.
    - Patient pN0 ou pNx (curage ganglionnaire au moment de la prostatectomie négatif ou absence de curage ganglionnaire).
    - Patient sans aucun signe clinique de maladie évolutive (la réalisation d’une scintigraphie osseuse et d’un scanner pelvien est optionnelle).
    - Performance Status ECOG ≤ 1.
    - Espérance de vie ≥ 10 ans.
    - Taux de PSA ≤ 0,1 ng/mL après la prostatectomie.
    - Augmentation du taux de PSA avant l’inclusion authentifiée sur trois dosages successifs, effectués dans le même laboratoire, à deux mois d’intervalle minimum (nadir suivi de deux autres dosages progressifs).
    - Taux de PSA ≥ 0,2 et < 2 ng/mL à la date d’inclusion.
    - Délai de 6 mois minimum entre la chirurgie et la récidive biologique.
    - Consentement éclairé signé.
    E.4Principal exclusion criteria
    - Cancer de prostate d’histologie autre qu’adénocarcinome.
    - Patient pN1 (envahissement ganglionnaire prouvé histologiquement lors du curage initial).
    - Castration chirurgicale ou chimique.
    - Traitement antérieur par hormonothérapie.
    - Antécédents d’un autre cancer invasif dans les 5 ans précédant l’inclusion (à l'exception d’un carcinome cutané baso-cellulaire traité).
    - Antécédents de radiothérapie pelvienne.
    - Adénome hypophysaire connu.
    - Hypertension artérielle grave non contrôlée par un traitement adapté (≥ 160 mm Hg en systolique et/ou ≥ 90 mm Hg en diastolique).
    - Traitement antinéoplasique en cours.
    - Personnes privées de liberté ou sous tutelle.
    - Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques.
    E.5 End points
    E.5.1Primary end point(s)
    - Efficacité
    - Toxicité
    - Autres critères :
    La qualité de vie avant le traitement, au décours et à distance de l’irradiation,
    La dépendance fonctionnelle avant le traitement, au décours et à distance de l’irradiation
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state466
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-02-18
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